General Introduction to the Protection of Plant
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1. International Aspects of Plant Variety Protection 2. India’s Position: PVPFR Act 10BT81 Unit 8 1 INTRODUCTION . Importance of modern biotechnology in plant breeding . IPR protection is independent from commercialization procedures . Issues resulting from the differences between the scope and the exceptions of the patent and breeder’s rights systems 2 Exclusion from patentability Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation If necessary to protect public order or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by domestic law. Art.27 (2) 3 Exclusion from patentability . Members may also exclude from patentability: a) Diagnostic, therapeutic and surgical methods for the treatment of humans or animals; b) Plants or animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system by any combination thereof {Art.27(3) (b)} 4 Article 27 (3)(b) of TRIPS “…members shall provide for the protection of plant varieties either by patents or an effective sui generis system or by any combination thereof” . For developing using a national yardstick, an effective system would stimulate research and development of plant varieties without compromising national welfare goals. It would prioritize goals like: Food security. Biodiversity protection Sustainable development of indigenous communities, etc. International Aspects: UPOV PLANT VARIETY PROTECTION CRITERIA : . Distinctiveness . Uniformity . Stability . Novelty . Appropriate Denomination (for sale) 7 Novelty Requirements Commercial Novelty: Art. 6 of UPOV The variety shall be deemed to be new if, at the date of filing of the application for a breeder's right, propagating or harvested material of the variety has not been sold or otherwise disposed of to others, by or with the consent of the breeder, for purposes of exploitation of the variety •Excludes cultivation, reference collection, publication etc,. •Allows the breeder to claim protection over genetic varieties that have been cultivated for centuries but never sold. Distinctiveness Requirement Article 7 of UPOV: . “The variety shall be deemed to be distinct if it is clearly distinguishable from any other variety whose existence is a matter of common knowledge at the time of filing the application.” Application materials that are a matter of common knowledge can pass the test of distinctiveness if it can be distinguished from another material that is a matter of common knowledge. Art 14: . A variety is “a matter of common knowledge,” under article 14 of UPOV, if it has been subject “of an application for the granting of a breeder's right” or has been entered in the official register of varieties, in any country” UPOV 1961, 1978, 1991 1961 European Convention: Requirements: – New – Distinct – Stable – Uniform – Biological deposit 1978 Act: Scope of protection • Authorization of the breeder is required for: – Production for the purpose of commercial marketing; – Offering for sale; and – Marketing of the reproductive or vegetative material, as such, of the variety • Protection may be extended to the harvested product • Exception to Breeder’s Right (for creating new varieties)11 1991 UPOV • Strengthen breeders’ rights • Weakened exemptions to breeders’ rights, particularly farmer’s exemption • Removed prohibition on dual protection U.S. PVPA (amended 1994) patterned after UPOV 1991 Plant variety certificates 12 UPOV 1991 Act Scope of protection 1978 Act (Article 5(1)) 1991 Act (Article 14(i)) Production for the purposes of Production or reproduction (multiplication) commercial marketing Conditioning for the purpose of propagation Offering for sale Offering for sale Marketing Selling or other marketing activities Exporting Importing Stocking for any of the above purposes 13 The 1991 Act . The protection is extended to the harvested material obtained through the unauthorized use of propagating material . Each contracting party may extend the protection to the products made directly from the harvested material . Unless, in both cases, the breeder has had a reasonable opportunity to exercise his right in relation to the propagating material . The authorization of the breeder is required for the exploitation of essential derived varieties (EDV) of a protected variety. 14 The 1991 Act Exceptions to the Breeder’s Right (1) Compulsory exceptions: . Acts done privately and for non-commercial purposes . Acts done for experimental purposes . Acts done for the purpose of breeding other varieties and, except if the new variety is essentially derived, exploitation of that new variety 15 The 1991 Act Exceptions to the Breeder’s Right Optional exception: . Each contracting party may, within reasonable limits and subject to the safeguarding of the legitimate interest of the breeder, restrict the breeder’s right in order to permit farmers to use, on their own farm, farm saved seeds 16 Plant Breeder’s Rights Conclusions . The 1978 UPOV Convention is a weak protection system, probably non “effective” in the meaning of the TRIPs Agreement . The 1991 UPOV Convention is an effective protection system, provided that the clause on farm saved seed is implemented properly by the contracting parties 17 Utility Patents for Plant Varieties . The first utility patent for a plant in the USA was granted in 1986 for a high-tryptophan corn . Since 1986 hundreds of utility patents have been granted for plant varieties in the USA . It is also possible to grant patents for plant varieties in other countries, such as Japan and Australia, but that possibility is not used frequently by seed companies 18 Utility Patents for Plant Varieties Perceived avantages of Utility Patents by some companies . Balancing the protection of plant varieties with the protection of biotech inventions . Ban of farm saved seed in general . Elimination of the breeder’s exception 19 TRIPS Agreement UPOV (Article 28) (1991 Act – Article 14) “1. A patent shall confer on its owner the “(1) [Acts in respect of the propagating following exclusive rights: material] (a) where the subject matter of a (a) Subject to Articles 15 and 16, the patent is a product, to prevent third following acts in respect of the propagating parties not having the owner’s material of the protected variety shall consent from the acts of: require the authorization of the breeder: making, (i) production or reproduction using, (multiplication), (ii) conditioning for the purpose of propagation, offering for sale, (iii) offering for sale, selling, or (iv)selling or other marketing, Importing (v) exporting, (vi) importing, for these purposes that product;” (vii) stocking for any of the purposes20 mentioned in (i) to (vi), above.” Exceptions to the rights conferred by a patent . Article 30 of the TRIPS Agreement states that: “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.” . Open multilateral treaties in the field of patents do not provide for the extent to which those limited exceptions may be permitted . Necessary to refer to national or regional patent legislation and to relevant jurisprudence 21 The ability to exercise the breeder’s exemption in the case of varieties containing patented inventions . purpose of the patent is to protect the developer of the genetic element . purpose of the plant breeder’s right is to protect the developer of the unique combination of plant germplasm forming the variety . exercise of breeder’s exemption constrained due to lack of similar provision in patent system 22 European Union . European Patents Convention, 1973: single application is enough. EU Directive on the Legal Protection of Biotechnological Inventions 1988/1995 . European Council for Regulation of Community wide system of Plant Variety Rights, 1994. EPC prohibits patents for plant varieties. Microbiological processes are patentable. 1994 law provides rights for plant varieties and EDV. Farmers’ privilege only through national laws. 23 PPV& FR Act, 2001 24 Protection of Plant Varieties & Farmers’ Rights Act, 2001 . Passed to provide an alternative protection to plant varieties as provided in Art. 27(3) of TRIPS. Objectives: 1. Establishing an effective system of protection of plant varieties. 2. Protection of farmers’ rights. 3. Protection of plant breeders’ rights. Functions of the Authority: I. Promoting and encouraging development of new varieties of plants. II. Protecting the rights of farmers and breeders. 25 Mechanism for Achievement . Registration of extant new varieties. Developing characterisation and documentation of registered varieties. Documentation, indexing and cataloguing of farmers’ varieties. Compulsory cataloguing for all varieties of plants. Ensuring that registered seeds are available to farmers. Collection of statistics of plant varieties. Ensuring maintenance of register. 26 Registerable Varieties: Sec 15 . A new variety: novelty, distinctiveness, uniformity & stability. An extant